Acute ischemic stroke
Conditions
Interventions
The Tirofiban group:Teneplase thrombolysis was followed by intravenous tirofiban.
Placebo group:Receive intravenous placebo
Sponsors
Ganzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of >=2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more); 3. NIHSS = 4 points before randomization; 4. The patient or their family members sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization; 2.CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery; 3.Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction <40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score =2 indicating high thromboembolic risk; 4.Blood platelet count was lower than 100×10^9/L; 5.Renal insufficiency, glomerular filtration rate <30 mL/min; 6.Pregnant or lactating women; 7.Allergic to tirofiban, nickel, titanium or their alloys; 8.Prior neurological or psychiatric illness that prevents assessment of neurological function; 9.Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis; 10.Brain tumors with a space-occupying effect on imaging (other than micromeningiomas); 11.Intracranial aneurysm, arteriovenous malformation; 12.Life expectancy of any advanced disease <6 months; 13.Participating in other clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS of 0-1 within 90 days;proption of symptomatic intracranial hemorrhage (SICH) , SICH defined as per the Heidelberg bleeding classification;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ordinal degree of disability on the mRS at 90 days;90 days EQ-5D-5L scale score;Incidence of non-hemorrhagic serious adverse events;Proportion of patients with mRS of 0-3 within 90 days;Proportion of patients with mRS of 0-2 within 90 days;Proportion of early neurological function improvement;Radiologic intracranial hemorrhage rate within 48 hours;Other serious adverse events;90 days mortality rate; | — |
Countries
China
Contacts
Public ContactZeng Guoyong
Ganzhou People's Hospital
Outcome results
None listed